510(k) K051888

TOTAL INTACT PTH IMMUNORADIOMETRIC ASSAY (COATED TUBE VERSION), MODEL 3KG013 by Scantibodies Laboratory, Inc. — Product Code CEW

K051888 is an FDA 510(k) premarket notification submitted by Scantibodies Laboratory, Inc. for the device "TOTAL INTACT PTH IMMUNORADIOMETRIC ASSAY (COATED TUBE VERSION), MODEL 3KG013". The FDA issued a decision of Substantially Equivalent on October 18, 2005. The device falls under product code CEW (Radioimmunoassay, Parathyroid Hormone), a Class II device regulated under 21 CFR 862.1545. Scantibodies Laboratory, Inc. has at least 10 other 510(k) clearances on record.